Endometrial CancerNCT03931265
Ketohexokinase Isoforms in Endometrial Cancer.
An observational study of Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- ketohexokinase
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2019to 31 Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital
Who may be able to join
- >20 years
- Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
- Women who have undergone gynecological staging surgery for endometrial cancer in the past.
Who cannot join
- Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Official title: Prognostic Evaluations of Ketohexokinase Isoforms in Endometrial Cancer
Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.
- Conditions
- Endometrial Cancer
- Being tested
- ketohexokinase
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketohexokinaseDiagnostic test
Check the isoforms of ketohexokinase in the specimen of endometrial cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of ketohexokinase isoforms in the overall survival of endometrial cancer.
Cox proportional hazard regression to evaluate the role of ketohexokinase isoforms in the overall survival of endometrial cancer.
Measured: 5 years
Secondary outcomes (1)
Correlation of ketohexokinase isoforms with the other prognostic risk factors
Correlation of ketohexokinase isoforms with deep myometrial invasion, tumor grade, lymph node metastasis, FIGO stage, tumor size, progression-free survival, etc.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start11 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931265
- Sponsor's protocol ID
- 108009-F
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2019
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Evaluations of Ketohexokinase Isoforms in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03931265
- Acronym / sponsor ID
- 108009-F
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Gynecologic Oncology Group
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital
Key inclusion criteria (3 listed)
- >20 years
- Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
- Women who have undergone gynecological staging surgery for endometrial cancer in the past.
Key exclusion criteria (1 listed)
- Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketohexokinaseCheck the isoforms of ketohexokinase in the specimen of endometrial cancer | Diagnostic test | – |
Primary outcome
The role of ketohexokinase isoforms in the overall survival of endometrial cancer.
Time frame: 5 years
Cox proportional hazard regression to evaluate the role of ketohexokinase isoforms in the overall survival of endometrial cancer.
1 secondary outcome
Correlation of ketohexokinase isoforms with the other prognostic risk factors
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+886289667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of ketohexokinase isoforms in the overall survival of endometrial cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.